Vascular medical devices with sealing elements and procedures for the treatment of isolated vessel sections

Abstract

Devices for the isolation of a selected portion of a vessel are described. In some embodiments, the device comprises an introducer sheath and a sealing catheter that are movable relative to each other to create an isolated volume with adjustable size and location. The methods for the treatment of vascular aneurysms using the devices are described. The treatment is achieved through the delivery of an effective amount of stabilization agent to an isolated volume that encompass the aneurysm. The device optionally has an aspiration means to improve the effectiveness of the treatment.

We claim: 
     
       1. A method for treating an isolated portion of a blood vessel, the method comprising:
 positioning an isolation device within the blood vessel wherein the isolation device comprises a sealing catheter and an introducer sheath, and the positioning of the isolation device comprises positioning the introducer sheath into the femoral artery in one of the legs of a patient and delivering the sealing catheter through the introducer sheath to place the first extendable element in the aorta, wherein the sealing catheter comprises a first extendable element, a first fluid exchange opening, a first fluid exchange lumen, and a first proximal connection port, wherein the introducer sheath comprises a second extendable element, a second fluid exchange opening, and a second fluid exchange lumen, wherein the extendable elements are movable relative to each other, wherein a first flow path extends from the first proximal connection port through the first fluid exchange lumen to the first fluid exchange opening of the sealing catheter, and wherein a second flow path extends from the second proximal connection port through the second fluid exchange lumen to the second fluid exchange opening of the introducer sheath; 
 isolating the selected portion of the blood vessel by adjusting the relative positions of the extendable elements and extending the two extendable elements to contact the walls of the vessel to form the isolated portion; 
 aspirating fluid from the isolated portion through the second flow path; and 
 delivering a therapeutic composition to the isolated segment of the blood vessel through the first flow path after aspiration of fluid from the isolated portion of the blood vessel. 
 
     
     
       2. The method of  claim 1  wherein the first extendable element is placed in the aorta below the renal arteries. 
     
     
       3. The method of  claim 1  wherein an additional sealing device is deployed in the femoral artery in the other leg of the patient to isolate a “Y” shaped portion of the blood vessel along with the first and the second extendable elements. 
     
     
       4. The method of  claim 3  wherein the additional sealing device is an introducer sheath and wherein an endovascular treatment device is delivered into the isolated section of the blood vessel through the additional sealing device. 
     
     
       5. The method of  claim 1  wherein the therapeutic composition comprises a phenolic elastin stabilizing composition. 
     
     
       6. The method of  claim 1  wherein the therapeutic composition further comprises a distinct collagen crosslinking agent. 
     
     
       7. The method of  claim 1  wherein the isolated portion of the blood vessel comprises an aneurysm. 
     
     
       8. The method of  claim 7  wherein the volume of the aneurysm is reduced following aspiration by at least about 10 percent wherein the volume of the aneurysm is evaluated as the excess volume in comparison with a corresponding healthy vessel lacking an aneurysm. 
     
     
       9. The method of  claim 1  wherein the therapeutic composition further comprises a contrast agent. 
     
     
       10. The method of  claim 1  wherein the step of delivering the therapeutic composition is repeated with a different composition, wherein the delivery of one therapeutic composition comprises the delivery of an elastin stabilization composition and the delivery of the other therapeutic composition comprises the delivery of a collagen stabilization composition. 
     
     
       11. The method of  claim 10  wherein the collagen stabilization composition comprises glutaraldehyde, carbodiimides, photo-oxidation agent, genipin, epoxies, or azide esters. 
     
     
       12. The method of  claim 1  further comprising a pretreatment step before the delivery of the therapeutic composition wherein the pretreatment step comprises the delivery of a thrombolytic composition to break up thrombus in the isolated blood vessel. 
     
     
       13. The method of  claim 10  wherein the aspiration and delivery steps can be performed at least partially simultaneously with the rate of aspiration consistently greater than the delivery. 
     
     
       14. The method of  claim 1  wherein the first extendable element is a compliant balloon with concaved ends that is positioned at or near the distal end of the sealing catheter and is inflated through a first balloon inflation lumen in the sealing catheter to make compliant contact with the wall of the aorta. 
     
     
       15. The method of  claim 1  wherein the second extendable element is a sealing balloon attached on the distal end of the introducer sheath and is inflated through a second balloon inflation lumen in the introducer sheath to make contact with the wall of femoral artery and wherein the isolated portion of the blood vessel is created between the compliant balloon of the sealing catheter and the sealing balloon of the introducer sheath.